• Recommendation follows an Article 20 non-pharmacovigilance procedure 
• Patients currently on TAVNEOS treatment should consult their treating physician  

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the revocation of the European Union (EU) marketing authorisation for TAVNEOS® (avacopan). TAVNEOS is a treatment for adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the main forms of ANCA-associated vasculitis. TAVNEOS is indicated for use in combination with rituximab or cyclophosphamide. 

The CHMP opinion has been provided to the European Commission (EC), and a final decision by the EC is expected shortly. If this recommendation is confirmed by the European Commission, TAVNEOS will no longer be authorised in the EU. 

The recommendation to revoke the marketing authorisation is based on a review of TAVNEOS under an Article 20 non-pharmacovigilance procedure that was initiated due to concerns related to data handling in the pivotal Phase 3 ADVOCATE trial. TAVNEOS was developed by ChemoCentryx and is commercialised outside the US and in selected countries by CSL, its affiliates and partners pursuant to a collaboration and license agreement between Vifor Fresenius Medical Care Renal Pharma Ltd. and ChemoCentryx. Amgen acquired ChemoCentryx in 2022.  

"While we are disappointed in the outcome of the Article 20 procedure, we will respect the outcome of the regulatory process and are committed to implementing it in full. We recognise this is a difficult moment for the community, as TAVNEOS has played an important role for patients living with ANCA-associated vasculitis, a life-threatening disease with limited treatment options. VFMCRP and CSL remain focused on bringing innovative treatment options to patients living with rare diseases," said Dr. Bill Mezzanotte, Head of Research and Development, CSL. "Patient care remains our highest priority, and we are working closely with regulatory authorities, healthcare professionals and patient organisations to ensure a compliant and appropriate treatment transition, along with ongoing support for patients." 

No new patients will be treated with TAVNEOS in the EU and the European Economic Area. Patients currently on TAVNEOS are advised to consult with their physician.